Revive Therapeutics Ltd (CNSX: RVV)(OTCMKTS: RVVTF) is among the most exciting drugs in small caps that saw a parabolic rise this year as its wunderdrug Bucillamine continues to demonstrate significant potential as a treatment therapy for HIV, Lung Cancer, Cystic Fibrosis to name just a few. Bucillamine is proving especially effective in the treatment of respiratory diseases such as coronavirus – covid 19. If Bucillamine is able to compete with or eventually replace NAC as the #1 lung anti-inflammatory the possibilities are endless.
Bucillamin is currently in a U.S. FDA Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine in patients with mild-moderate COVID-19 called “A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of Bucillamine in Patients with Mild-Moderate COVID-19”, Revive’s CEO Michael Frank stated: “We are one of a few life sciences companies evaluating an investigational drug in a Phase 3 clinical trial for COVID-19 and with the rising prevalence of cases throughout the U.S., we are confident that our targets will be achieved to support the potential FDA approval and commercialization of Bucillamine for the treatment of the virus.”
Revive Therapeutics Ltd (CNSX: RVV)(OTCMKTS: RVVTF) is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders, and it is prioritizing drug development efforts to take advantage of several regulatory incentives awarded by the FDA such as Orphan Drug, Fast Track, Breakthrough Therapy and Rare Pediatric Disease designations. Currently, the Company is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19. With its recent acquisition of Psilocin Pharma Corp., Revive is advancing the development of Psilocybin-based therapeutics in various diseases and disorders. Revive’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory diseases and the company was granted FDA orphan drug status designation for the use of Cannabidiol (CBD) to treat autoimmune hepatitis (liver disease) and to treat ischemia and reperfusion injury from organ transplantation. Revive owns a valuable intellectual property portfolio including 5 issued patents and 7 provisonal patents filed. The Company’s subsidiary Psilocin Pharma Corp. has developed production solutions for the active compound Psilocybin. Its process encompassed with intellectual property that covers methods of production of Psilocybin based formulations. Visit psilocinpharma.com. Click here for press release regarding the acquisition.
Revive is led by CEO Michael Frank, an executive with a strong background in operations, business development, M&A and the capital markets. Mr. Frank has served as the CEO and Director of Sprylogics International and the Internet of Things Inc., as well as holding senior management positions at Ernst & Young, Data General, and NCR. Mr. Frank has had successful exits in the technology sector including one to Intuit Corporation, and has been instrumental in advising several early stage software companies.
Revive’s U.S. FDA Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine in patients with mild-moderate COVID-19 called “A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of Bucillamine in Patients with Mild-Moderate COVID-19”, will enroll up to 1,000 patients that will be randomized 1:1:1 to receive Bucillamine 100 mg three times a day (“TID”), Bucillamine 200 mg TID or placebo TID for up to 14 days. The primary objective is to compare the frequency of hospitalization or death in patients with mild-moderate COVID-19 receiving Bucillamine therapy with those receiving placebo. The primary endpoint is the proportion of patients meeting a composite endpoint of hospitalization or death from the time of the first dose through Day 28 following randomization. Efficacy will be assessed by comparing clinical outcomes (death or hospitalization), disease severity using the 8-category NIAID COVID ordinal scale, supplemental oxygen use, and progression of COVID‑19 between patients receiving standard-of-care plus Bucillamine (high dose and/or low dose) and patients receiving standard-of-care plus placebo. Safety will be assessed by reported pre-treatment adverse events and treatment-emergent adverse events (including serious adverse events and adverse events of special interest), laboratory values (hematology and serum chemistry), vital signs (heart rate, respiratory rate, and temperature), and peripheral oxygen saturation.
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In an October update Revive stated it has committed to ten clinical sites across Florida, Texas, Nevada, Arizona and California, and it is estimated that over 200 patients will have completed the Study for the interim analysis by the end of December 2020. The interim analysis will determine the better performing Bucillamine dose arm for the remainder of the trial and future complementary studies evaluating it in more severe cases, thus making Bucillamine a potential treatment option.
An interim analysis will be performed by an Independent Data and Safety Monitoring Board (“DSMB”) after 210 patients have been treated and followed up for 28 days after randomization. The better performing Bucillamine dose at the interim analysis will be selected and patients will then be randomized 2:1 to the selected Bucillamine dose or placebo. Additional interim analyses will be performed after 400, 600, and 800 patients have reached this same post-treatment timepoint. The independent DSMB will actively monitor interim data for the ongoing safety of patients and will recommend continuation, stopping or changes to the conduct of the study based on the interim analysis reports.
On November 18 Revive entered into a collaboration agreement with PharmaTher Inc., to accelerate the development of psilocybin in the treatment of cancer and the discovery of novel uses of undisclosed psychedelic compounds.
Revive CEO Michael Frank stated: “Revive continues to be focused on developing novel uses for psilocybin that leverages our proprietary oral thin film delivery technology as a differentiated therapeutic approach. We are excited to advance the development of PharmaTher’s recent discovery in the potential of psilocybin to treat certain cancers such as Liver Carcinoma, Melanoma, Breast Neoplasms, Kidney Neoplasms and Acute Myeloid Leukemia. We are also leveraging PharmaTher’s panaceAI™ discovery AI platform to discover new uses of undisclosed psychedelic compounds to be potentially used with our oral thin film delivery technology and expand our psychedelics drug pipeline.”
— Kenny (@shurtleff_k) November 25, 2020
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Currently moving northbound Revive is among the most exciting drugs in small caps that saw a parabolic rise this year as its wunderdrug Bucillamine gains serious traction. Bucillamin is currently in a U.S. FDA Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine in patients with mild-moderate COVID-19 called “A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of Bucillamine in Patients with Mild-Moderate COVID-19. Bucillamine is a respiratory treatment therapy for ALL respiratory diseases and is currently being used to treat the following: Acetaminophen overdose, Chronic bronchitis, protect liver, Repair kidney damage, Neurologic damage, Help in prevention of colon cancer, Asthma, COPD, Emphysema, Lung Cancer. Cystic Fibrosis, Pneumonia, Pleural Effusion, Infertility, Flu, Influenza, HIV, High Cholesterol, Several Eye Conditions and coronavirus. If Bucillamine is able to compete with or eventually replace NAC as the #1 lung anti-inflammatory the possibilities are endless. We will be updating on Revive on a daily basis so make sure you are subscribed to microcapdaily.com so you know what is going on with Revive.